Eg-Conformiteitsverklaring; Ec Declaration Of Conformity - ENBIO S Mode D'emploi

10. EG-CONFORMITEITSVERKLARING

EC Declaration of Conformity

Company: Enbio Group AG, Eichengasse 3, 4702 Oensingen, Switzerland
declares with sole responsibility, that medical devices: STEAM STERILIZER
(model):
ENBIO S
ENBIO PRO
complies with provisions of Council Directive 93/42/EEC of 14 June 1993 on medical devices (as
amended). The device has been classified in Class IIb in accordance with rule 15 of Annex IX of the
abovementioned Directive
Conformity assessment has been carried out in accordance with Annex II without point 4 of the
above Regulations.
The conformity assessment has been conducted by the Notified Body No. 2274
TUV Nord Polska Sp. z o.o.
ul. A. Mickiewicza 29, 40-085 Katowice, Poland
Sebastian Magrian
Oensingen
17.01.2020
President of the
Board of Directors
119
Version: 03_01.2020
Simon Schaefer
Member of the Board